Phase 1
Completed N=20
A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
Healthy
Source: ClinicalTrials.gov NCT01161472 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Computer Based Objective Cognition Testing (CogState) Detection Speed — 2.6333; 2.5971; 2.6103; 2.5842 Log10 MS
Summary
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Computer Based Objective Cognition Testing (CogState) Detection Speed |
2.6333; 2.5971; 2.6103; 2.5842 | — |
| PRIMARY Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 |
-0.0201; -0.0119; 0.0684; 0.0084 | 0.1198 |
| SECONDARY CogState Identification Speed |
2.7540; 2.7672; 2.7577; 2.7457 | — |
| SECONDARY Change From Baseline in CogState Identification Speed on Day 6 |
0.0105; 0.0057; 0.0817; 0.0142 | 0.7502 |
| SECONDARY CogState One Card Learning |
0.9585; 0.9421; 0.9531; 0.9302 | — |
| SECONDARY Change From Baseline in CogState One Card Learning on Day 6 |
-0.0094; 0.0151; -0.0880; -0.0058 | 0.8944 |
| SECONDARY CogState Continuous Paired Associate Learning (CPAL) |
96.33; 99.83; 89.50; 107.44 | — |
| SECONDARY Change From Baseline in CogState CPAL on Day 6 |
6.7933; -16.7905; 58.2002; 3.1304 | 0.7707 |
| SECONDARY CogState Groton Maze Learning Task (GMLT) |
53.72; 58.39; 56.83; 52.28 | — |
| SECONDARY Change From Baseline in CogState Groton Maze Learning Task on Day 6 |
-4.1399; -5.7717; 24.7115; -4.1467 | 0.9989 |
| SECONDARY Rey Auditory Verbal Learning Test (RAVLT) |
6.50; 6.67; 7.22; 6.33 | — |
| SECONDARY Rey Auditory Verbal Learning Test (RAVLT) on Day 6 |
0.1565; -0.1780; -3.9222; -0.1119 | 0.7458 |
Eligibility Criteria
Inclusion Criteria
- Adult healthy volunteers 65 years and over with minimum MMSE of 26
Exclusion Criteria
- Prohibited concomitant medications
- Confounding medical conditions
- Clinically significant comorbid diseases
- Hypersensitivity or contraindications to fesoterodine or active control
Data sourced from ClinicalTrials.gov (NCT01161472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.